Suing over silicone

French-made breast implants raise public health concerns

The tragic death of Edwige Ligonèche on November 11, 2011 has raised questions about the role that her breast implants- – manufactured by French company Poly Implant Prothèse (PIP) – may have played in her illness. Ligonèche received the implants in 2005, and two years later was diagnosed with analplastic large-cell lymphoma (ALCL), a rare form of cancer that affects cells of the immune system. These cancerous cells developed in the capsular scar tissue surrounding the leakage areas on the implants, and subsequently, Ligonèche’s family launched an involuntary manslaughter case against PIP. The current case is being dealt with separately from the original investigations that shut down the company in 2010.

The March 2010 scandal has now been reignited with the more than 2,400 women, including the Ligonèche family, who have made criminal complaints in France. PIP, originally located in La Seyne-sur-Mer in southwest France, had been producing implants ﬁlled with industrial-grade silicon not approved by the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), the French equivalent of the American Food and Drug Administration. By using industrial-grade silicon, PIP managed to spend a tenth of what they would have using medical-grade silicon. However, due to the decreased viscosity of the silicon used, many surgeons reported abnormally high rupture and leakage rates of up to 11 per cent. These reports lead to the AFSSAPS investigation which, in the summer of 2010, found that PIP had been using a “homemade” blend of silicon since 2001. These findings resulted in a complete recall of all PIP silicone implants from the worldwide market. The recall cost PIP over 9 million Euros, and the company subsequently ﬁled for bankruptcy.

Six former PIP executives, including the CEO Jean-Claude Mas, are expected to be sentenced later this year by a Marseilles court in accordance with the March 2010 investigations regarding charges of aggravated fraud. Currently, Mas cannot be found, and has been missing since the March 2010 debacle. PIP’s lawyers have reassured the French Health Minister, Xavier Bertrand, that Mas is still within the country, somewhere in southern France.

Interestingly, no direct linkage has been found between the industrial-grade silicon used and ALCL, as French and UK health authority tests have failed to ﬁnd any chemical toxicity or genotoxicity related to the gel ﬁller. However, the French Society of Plastic, Reconstructive, and Aesthetic Surgery claims the gel could have been an “aggravating factor”. On December 23, the French health authority advised some 30,000 women with PIP implants to have them removed or replaced, and promised to cover the procedure with public funds if the initial implants were inserted for medical reasons, such as after post breast cancer reconstruction. As of right now, there is no promise of monetary aid provided for women who had PIP implants inserted for cosmetic reasons.

In a less intensive act, the British and Brazilian governments have not advised women to have PIP implants removed because “no evidence of a link to cancer or an increased risk of cancer” has been found with the industrial-grade silicon, according to Dame Sally Davis, the British Chief Medical Ofﬁcer. However, both governments have advised all women to undergo periodic and frequent check-ups with their surgeons.

Troublingly, Mas’ son, Nicolas Lucciardi, has just founded a company named France Implant Technologie (FIT) at Six-Fours-les-Plages, next to La Seyne-sur-Mer. In the business model, FIT is listed as a manufacturer for medical-surgical and dental materials. And, further complicating the situation, Mas is listed as the Technical and Commercial consultant at the not-yet-formed company. The business model further plans on hiring two former PIP executives, and operations are expected to commence on the same site as PIP in La Seyne-sur-Mer.

France is calling on the European Union to tighten prostheses regulations, as they currently only require a quality certiﬁcation and no strenuous clinical trials. The results of the Marseilles aggravated fraud sentence will be crucial towards changing future EU policies. But as for the recently ﬁled lawsuit of involuntary manslaughter, it is too soon to tell.